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Diss Factsheets
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EC number: 214-482-7 | CAS number: 1134-23-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- EPA Pesticide Assessment Guidelines - Subdivisions F, hazard Evaluation - Human and Domestic Animals - Revised edition. U.S. Environmental Protection Agency, Washington D.C., 1984
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- A vizsgálathoz szükséges SPF Wistar törzsű hím és nőstény állatokat a LATI Közös Vállalatól szerezték be 4 hetes korban. A vizsgálatot 6 hetes állatokon kezdték el.
Az állatokat klimatizált, jól szellőztetett állatszobában, II. típ. állattartó edényben helyezték el, száraz, vegyes faforgács almon. Az állatházban fényprogram alapján 12-12 órás megvilágítást, illetve sötétséget, 21 +- 2 C hőmérsékletet biztosítottak. A légtér relatív páratartalma legalább 40-50% volt.
A viszgálatba vont állatok standard LATI patkánytápt és csapvizet ad libitum fogyasztottak. - Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on oral exposure:
- 0,19,41,75 mg/ 100 g feed
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Packard 419 type Gas chromatography was used for analytical verification.
Hőmérséklet inj: 190 C
kolonna: 165 C
detektor: 220 C
töltet: 10% SE-52 Chromosorb WAW DMCS 80-100 mesh
oszlophossz: 1m, belső átmérő: 2mm
vivőgáz: nitrogén, hidrogén és levegő mennyisége, detektor optimum szerint - Duration of treatment / exposure:
- 18 months
- Frequency of treatment:
- 0,19,41,75 mg/ 100 g feed
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 10 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 21 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 39 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 15 male and 15 female
- Control animals:
- yes
- Observations and examinations performed and frequency:
- szemvizsgálat, túlélés, viselkedés, testtömeg és takarmány/víz-fogyasztás, vizeletvizsgálat, hematológiai vizsgálat, klinikai kémiai vizsgálatok, kórbonctani vizsgálat, szervtömeg mérés, kórszövettani vizsgálat,
- Sacrifice and pathology:
- Kóronctani vizsgálat: minden állatot (CO2-vel történt túlaltatás után) feldolgoztak. A makroszkópikus megfigyelés kiterjedt az általános erőnléti állapotra, testnyílásokra, a kültakaróra és a belső szervekre. Az esetleges elváltozásokat feljegyezték.
- Statistics:
- Az egyes dóziscsoportban számított, mért adatok kontrolltól való eltérésének statisztikai ellenőrzésére a Student-féle t-próbát alkalmaztuk. A varinacia homogenitás vizsgálatára a Bartlett próbát vettük igénybe.
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- NOEL no toxic effect level: female 21 mg/kg bw/day
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- az elváltozások nem hozhatók összefüggésbe a viszgálati anyag toxikus hatásával
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 21 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Effect: body weight changes
- Key result
- Dose descriptor:
- NOEL
- Remarks:
- highest dose examined
- Effect level:
- ca. 39 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: no significant effect for male rats
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 39 mg/kg bw/day (actual dose received)
- System:
- other: body weight
- Organ:
- not specified
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- yes
- Conclusions:
- The NOAEL is 21 mg/kg bw/day ( repeated dose toxicity female rat)
The NOEL is 39 mg/kg bw/day ( repeated dose toxicity male rat) - Executive summary:
The NOAEL is 21 mg/kg bw/day ( repeated dose toxicity female rat)
The NOEL is 39 mg/kg bw/day ( repeated dose toxicity male rat)
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 21 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- reliable very well documented
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity: via oral route - systemic effects (target organ) other: all gross lesions and masses
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.